P712 Tofacitinib efficacy in patients with moderate to severe ulcerative colitis: Subgroup analyses of OCTAVE Induction 1 and 2 and OCTAVE Sustain by 5-aminosalicylates use
Bibliographic record
Abstract
Tofacitinib is an oral, small-molecule JAK inhibitor approved in several countries for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in three Phase 3 trials (OCTAVE Induction 1 and 2, NCT01465763 and NCT01458951; OCTAVE Sustain, NCT01458574) in patients with moderate to severe UC [1]. In this post-hoc analysis, we explored tofacitinib efficacy for patients with (c5-ASA) and without (n5-ASA) concomitant 5-aminosalicylates use. In OCTAVE Induction 1 and 2, patients received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks; clinical responders were re-randomised into OCTAVE Sustain for 52 weeks and received placebo, tofacitinib 5 or 10 mg BID. c5-ASA were permitted at entry, provided doses were stable ≥4 weeks prior to and during the trials. Remission and mucosal healing were summarised at Week 8 (OCTAVE Induction 1 and 2) and Week 52 (OCTAVE Sustain) by c5-ASA status. Generalised linear models were used to compare the adjusted treatment effects between 5-ASA subgroups (Tables 1 and 2). A smaller proportion of c5-ASA patients had prior tumour necrosis factor inhibitor (TNFi) and immunosuppressant failure compared with n5-ASA patients, at baseline of OCTAVE Induction and Sustain (OCTAVE Induction 1 and 2: TNFi failure 42.7% vs. 74.5%; immunosuppressant failure 69.4% vs. 78.3%; OCTAVE Sustain: TNFi failure 36% vs. 70%; immunosuppressant failure 67.9% vs. 80%). For both c5-ASA and n5-ASA subgroups, a higher proportion of tofacitinib-treated patients achieved efficacy endpoints, compared with placebo-treated patients, at Week 8 of OCTAVE Induction 1 and 2 and Week 52 of OCTAVE Sustain (Tables 1 and 2). Without controlling for baseline variables, higher treatment effects were observed within the c5-ASA subgroup compared with the n5-ASA subgroup; however, when controlled for prior TNFi and immunosuppressant failure (and baseline remission status in OCTAVE Sustain), the differences were not statistically significant in treatment effects between the 5-ASA subgroups in terms of adjusted odds ratios (Tables 1 and 2). When controlling for prior UC treatment status, efficacy of tofacitinib, based on adjusted odds ratios, was similar regardless of 5-ASA status. This analysis is limited by subgroup size differences. References 1. Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376:1723–36.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.013 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".